BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS GREENLIGHT HPS FIBER

    MDR report key: 2865370 · Received October 22, 2012

    Report

    Report Number
    2937094-2012-01116
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    February 6, 2012
    Report Date
    March 25, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER ASSIGNED MODEL NUMBER 0010-2093 IS DESIGNATED FOR (B)(6) DISTRIBUTION. THIS REPORT IS BEING SUBMITTED AS THE MODEL 0010-2093 IS IDENTICAL IN DESIGN AND MANUFACTURE TO THE COMMERCIALLY AVAILABLE MODEL 0010-2090 ANGLED DELIVERY DEVICE, GREENLIGHT (K062719). FIBER ANALYSIS: THE FIBER CAP REMAINS INTACT AND ATTACHED AND DRILLED THROUGH; EXHIBITS DETRITUS, CHAR, DEVITRIFICATION, AND MELTED GLASS. CAP CONDITION WOULD RESULT IN REDUCED VAPORIZATION EFFICIENCY. THIS MAY CAUSE FORWARD FIRING. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE HEAT ACCUMULATION DUE TO TISSUE CONTACT AND OR TECHNIQUE AND ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, LIMITING THE PERFORMANCE OF THE FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIBER TIP WAS DAMAGED AT 192,750 JOULES DURING A PROSTATE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS GREENLIGHT HPS FIBER POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2093 124J

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESSORIES| GREENLIGHT HPS LASER SYSTEM